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A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes

NCT05373199 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-15

No results posted yet for this study

Summary

This is a randomised, double-blind, three-period crossover euglycaemic clamp trial comparing pharmacokinetics and pharmacodynamics of BC Combo THDB0207 and Lantus® and Humalog® in subjects with type 1 diabetes.

Each subject will be randomly allocated to one of the 6 treatment sequences and will be administered single subcutaneous doses of BC Combo THDB0207, Lantus®, and Humalog® at three separate dosing visits.

Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 24-hour clamp procedures have been terminated. Patients will return to the clinical trial centre for outpatient blood sampling visits for analysis of BC449 excipient until 144 hours after each dosing.

Conditions

Interventions

DRUG

Euglycemic clamp with BC Combo THDB0207

Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.

DRUG

Euglycemic clamp with Lantus®

Administration of a single dose of Lantus® during an euglycemic clamp procedure.

DRUG

Euglycemic clamp with Humalog®

Administration of a single dose of Humalog® during an euglycemic clamp procedure.

Sponsors & Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Marc Stoffel, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2022-10-28
Completion
2022-10-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373199 on ClinicalTrials.gov